Minimally Invasive Cardiac Output Monitoring Device

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Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.

Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output

Description

The primary outcome of this work is to establish a dataset that would ...

Description

The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.

Time Frame

8 hours post cardiac surgery

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.

Arm/Group Title

Retia Non-Invasive Sensors

Arm/Group Description:

Sensors will be placed on the patie...

Arm/Group Description:

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.

All-Cause Mortality

Retia Non-Invasive Sensors

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

Retia Non-Invasive Sensors

Affected / at Risk (%)

Total

0/77 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The PI is not involved with the ultimate analysis of the data which is to be used for proprietary algorithm development. The PI was engaged with his opinion on algorithm development and review of waveform data.